Field safety and effectiveness of new visceral leishmaniasis treatment regimens within public health facilities in Bihar, India

by Goyal V, Mahajan R, Pandey K, Singh SN, Singh RS, Strub-Wourgaft N, Alves F, Das VNR, Topno RK, Sharma B, Balasegaram M, Bern C, Hightower A, Rijal SEllis S, Sunyoto T, Burza S, Lima N, Das P, Alvar JPLOS Neglected Tropical Diseases 2018, 12(10): e0006830. doi: 10.1371/journal.pntd.0006830

Summary: In 2010, WHO recommended the use of new short-course treatment regimens in kala-azar elimination efforts for the Indian subcontinent. Phase III studies had shown excellent results, but there remained a lack of evidence on a wider treatment population and the safety and effectiveness of these regimens under field conditions. Three treatment regimens were therefore tested within public health facilities in two highly endemic districts and a specialist referral centre in Bihar, India: single dose AmBisome®, concomitant miltefosine and paromomycin, and concomitant AmBisome® and miltefosine. All regimens showed acceptable outcomes and safety profiles in a range of patients under field conditions. This phase IV study contributed to national level policy change in India.

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